News

This episode focused on the most pressing unmet needs in RSV prevention and the clinical impact of newly approved options. Tan highlighted a key issue from the initial rollout of nirsevimab: supply ...
The June 9, 2025, FDA approval of clesrovimab (Enflonsia; Merck) marked another advancement for the prevention of respiratory syncytial virus (RSV) disease in infants, especially during their first ...
Respiratory syncytial virus (RSV) is a leading cause of hospitalization in infants and young children, placing a significant burden on families, hospitals, and the healthcare system. Recent ...
On June 18, Biogen announced the dosing of participants in the BRAVE study (NCT06953583), a global phase 3 clinical trial evaluating omaveloxolone (Skyclarys) in children aged 2 to younger than 16 ...
The FDA has approved, for patients aged 12 years and older, CSL's garadacimab-gxii (Andembry) to prevent attacks of hereditary angioedema (HAE), according to a press release from the company. With the ...
Among a study population of adults and adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) and skin of color, dupilumab (Dupixent; Regeneron Pharmaceuticals and Sanofi) ...
Michael O. Daines, MD, division chief of Pediatric Allergy and Immunology at the University of Arizona College of Medicine and principal investigator of the phase 3 trial evaluating Panzyga for ...
The FDA has accepted a new drug application (NDA) for epinephrine sublingual film (Anaphylm; Aquestive Therapeutics) to treat type 1 allergic reactions, including anaphylaxis. With the acceptance of ...
As RSV prevention tools expanded, clinicians faced new decisions around allocation, coordination, and outreach. In the final installment of this 3-part HCP Live Network RX Review roundtable, moderator ...
The FDA will not meet a prescription drug user fee act (PDUFA) date of June 17, 2025, for a decision regarding the potential approval of sebetralstat (KalVista Pharmaceuticals) to treat hereditary ...
On June 9, 2025, the FDA approved Merck's monoclonal antibody clesrovimab (Enflonsia) to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season, according to a ...
A study recently published in JAMA Pediatrics found that US states with permissive firearm laws saw significantly more pediatric firearm deaths following the 2010 Supreme Court ruling in McDonald v ...